title: Supporting pharmaceutical studies for FDA submissions: diversifying the drug monitoring laboratory.
abstract: Well-founded pharmacokinetic information is one of the cornerstones of a New Drug Application (NDA) to the Food and Drug Administration (FDA) required to introduce a new drug or a generic equivalent (ANDA) to the marketplace. The service that laboratories engaged in therapeutic drug monitoring provide to support clinical activities is also needed by the pharmaceutical industry during the evaluation and introduction of drugs to the marketplace. In considering this alternative service activity, one must be aware of and compliant with rules established by the FDA for performance of such studies. As specified in CFR 21, Parts 58, 211, and 320, good clinical and laboratory practice indicates that the laboratory should employ a Lab Study Director, who is responsible for the validation of all procedures implemented to support a study protocol, ensures that the laboratory carries out the study following these defined procedures, and personally reviews the results of all testing. The laboratory must validate each procedure by demonstrating and documenting that the procedure does what it is designed to do while meeting the analytical performance specifications required by the study. Laboratory records of all activities must be maintained and available for inspection by the FDA on request. The FDA has authority over all activities related to NDA and ANDA submissions and can bring criminal charges if results of a study are changed because a laboratory deviates from standard procedure. Competent drug monitoring laboratories are fully capable of participating in clinical trials testing activities. Laboratory staff should be fully versed in the FDA rules governing these activities, validate all procedures, and establish systems to verify the procedures are carried out as specified.
authors.affiliation: Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN 55905, USA.
authors.forename: T P
authors.initials: TP
authors.lastname: Moyer
authors.forename: L K
authors.initials: LK
authors.lastname: Oliver
mesh_terms: D002986:Clinical Trials as Topic; D017277:Drug Approval; D004345:Drug Industry; D016903:Drug Monitoring; D016568:Drugs, Generic; D006801:Humans; D017056:Medical Laboratory Personnel; D010599:Pharmacokinetics; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic